1. Field of the Invention
The present invention relates to an apparatus for inserting surgical material in the body. In particular the present invention relates to a delivery apparatus for a tissue augment that may be in form of a sheet to repair a tissue such as rotator cuff, bicep or quadriceps.
2. Description of Related Art
In order to repair a torn rotator cuff, the surgeons reattach the damaged tendon or tendons to the upper arm or humerus. For challenging tendon repair surgery, surgeons need a strong, suturable scaffold (i.e., tissue augment) to augment the repair both physically and biologically. Tissuemend® is an example of a suitable tissue augment sheet. Tissuemend® is a remodelable collagen scaffold derived from bovine skin to be used to reinforce soft tissue where weakness exists. It is specifically designed to serve as a scaffold for cellular and vascular ingrowth that is gradually remodeled into new tissue.
Surgical procedures such as shoulder rotator cuff repair with tissue augmentation are performed with traditional open, mini-open, and arthroscopic surgical technique. There are advantages to arthroscopic procedures over traditional open or mini-open procedures mostly due to improved visualization. Arthroscopic surgery is a technique for performing an operation using pen-shaped instruments with a miniature video camera attached to the end. Because arthroscopic surgery requires only limited surgical access, the incision is much smaller than is necessary for open surgery, resulting in fewer risks. The patient's recovery time is also shorter.
Current arthroscopic surgical procedures using tissue augmentation are higher cost due to prolonged surgical time. Surgical techniques are not user friendly requiring increased surgeon training to master the technique. Causes may range from difficult placement of augmentation tissue, challenging suturing technique and suture management. Many tissue augmentation products do not offer specifically designed arthroscopic instruments for implantation.
However, some applicators for applying surgical materials are known in the art. Conventional applicators require folding of the material that is to be inserted in the body cavity and then unfolding of the same inside the body cavity. Tightly folded sheet materials are difficult and time consuming to unfold.
U.S. Pat. No. 5,503,623 (the '623 patent) is directed at a method and apparatus for laparoscopic insertion and application of sheet like surgical material. To introduce and apply a large sheet like material, the '623 patent provides a method and apparatus of grasping and furling the sheet and then unfurling, releasing and applying it after passage into the patient's abdominal cavity. The apparatus consists of a grasping and furling portion which is rotated to furl the sheet like material. The furled material is then drawn into a tubular portion of the instrument. The tubular portion is introduced in the body through a valved port. Once the sheet like material is in the abdominal cavity it is unfurled. The need for furling and unfurling makes the process of insertion of the material complex, time consuming and prone to error.
U.S. Pat. No. 5,405,360 discloses an apparatus for positioning surgical implants adjacent to body tissue. The apparatus has a delivery device having a plurality of delivery arms positioned at the distal end of an elongated rod. A surgical implant is releasably secured to the delivery arms by a securing device such as sutures. The invention also provides a method for positioning surgical implants adjacent to body tissue. The apparatus uses a pusher rod to properly unfurl the surgical material being implanted.
Therefore, there is a need for a simple, easy to use tissue augment delivery system that allows accurate and fast placement of the scaffold.